Method and apparatus for ultrasonic treatment of lower tissues simultaneous with heating of subcutaneous, outer muscle and lower tissues

ABSTRACT

An ultrasonic frequency electro-mechanical therapeutic method and apparatus for treating an afflicted member, having skin, subcutaneous outer muscle and lower tissues, of a patient&#39;&#39;s body, the lower tissues including muscle, nerve, bone or joint tissues. A therapeutic applicator has an electrically energizable crystal for generating a mechanical energy wave and has a first pair of substantially parallel sides spaced apart a distance determinative of a first resonant frequency and a second side normal to the first pair of sides determinative of a second resonant frequency of at least 150 kHz selected for heating the lower tissues of a patient&#39;&#39;s body. The applicator includes a metallic electrode on each of the pair of sides, a housing in which the crystal is mounted and protective coating covering at least one of the pair of sides and forming an applicator side facing out of the housing. An ultrasonic energy generating circuit is coupled across the metallic electrodes and generates across the crystal an ultrasonic electrical signal and thereby a mechanical vibratory energy wave in the crystal, both having at least one frequency component equal to the second resonant frequency. Means generates heat adjacent the applicator side simultaneously with the mechanical vibratory energy and in the subcutaneous and outer muscle tissues of a patient&#39;&#39;s body in the afflicted member. The heat is sufficient to cause a heat rise in the subcutaneous and outer muscle in a range of 1* C to 24* C.

United States Patent [191 Mettler 11 3,828,769 Aug. 13, 1974 METHOD AND APPARATUS FOR ULTRASONIC TREATMENT OF LOWER TISSUES SIMULTANEOUS WITH HEATING OF SUBCUTANEOUS, OUTER MUSCLE AND LOWER TISSUES [76] Inventor: Hal C. Mettler, 16621 Carousel Ln.,

Huntington Beach, Calif. 91103 [22] Filed: Feb. 28, 1973 [21] Appl. No.: 336,783

Primary Examiner-Lawrence W. Trapp Attorney, Agent, or Firm-Christie, Parker & Hale 5 7 ABSTRACT An ultrasonic frequency electro-mechanical therapeutic method and apparatus for treating an afflicted member, having skin, subcutaneous outer muscle and lower tissues, of a patient's body, the lower tissues including muscle, nerve, bone or joint tissues. A therapeutic applicator has an electrically energizable crystal for generating a mechanical energy wave and has a first pair of substantially parallel sides spaced apart a distance determinative of a first resonant frequency and a second side normal to the first pair of sides determinative of a second resonantfrequency of at least 150 kHz selected for heating the lower tissues of a patients body. The applicator includes a metallicelectrode on each of the pair of sides, a hou qng in which the crystal is mounted and protective coating covering at least one of the pair of sides and forming an applicator side facing out of the housing. An ultrasonic energy generating circuit is coupled across the metallic electrodes and generates across the crystal an ultrasonic electrical signal and thereby a mechanical vibratory energy wave in the crystal, both having at least one frequency component equal to the second resonant frequency. Means generates heat adjacent the applicator side simultaneously with the mechanical vibratory energy and in the subcutaneous and outer muscle tissues of a patients body in the afflicted member. The heat is sufficient to cause a heat rise in the subcutaneous and outer muscle in a rangeof 1 C to 24 C. 1

24 Claim, 6 Drawing Figures METHOD AND APPARATUS FOR ULTRASONIC TREATMENT OF LOWER TISSUES SIMULTANEOUS WITH HEATING OF SUBCUTANEOUS, OUTER MUSCLE AND LOWER TISSUES BACKGROUND OF THE INVENTION This invention relates to ultrasonics and, more particularly, to a method for ultrasonic treatment of a patients afflicted member.

Ultrasonic energy is accepted by the medical profession as penetrating more deeply, and thus creating deeper heat in human and animal bodies than any other modality. An ultrasonically conductive vehicle such as oil or other a uous couplant is used to conduct the ultrasonic energy to the patient's member. I

Attempts have been made to use ultrasonic treatment at frequencies as low as 800 kHz (see page 294 of Electrotherapy and light Therapy by Kovacs; Lee and Fibiger, l949). However, in general, treatment below 800 kHz has not passed the experimental stage because of the sharp pain developed in the bone area. This sharp pain is not experienced with therapeutic treatment of higher frequencies. It is now believed that the sharp pain at lower frequencies comes about because applicators used have a piezoelectric crystal transducer which concentrates the ultrasonic energy over a small area at the center of the applicator.

Applicant built an ultrasonic generator which generates signals at 90 kHz using a crystal which emits ultrasonic energy in a substantially uniform pattern over the piezoelectric crystal. Applicant's generator was tested on a patient at a leading university and it was discovered that strikingly enhanced therapeutic efforts are obtained at 90 kHz using a crystal which emits ultrasonic energy in a substantially uniform pattern over the piezoelectric crystal. Centrally concentrated energy from crystals used prior to applicant's aforementioned device was obtained because the crystals had mechanical restraints. These mechanical restraints are eliminated by mounting the crystal such as that described in applicant's U.S. Pat. No. Re. 25,657. Also at lower frequencies thicker crystals are used, allowing the crystal to be supported by a thin diaphragm to which the crystal is affixed and still obtain a substantially uniform energy distribution.

With a substantially uniform energy pattern at 90 kHz it was found that greatly enhanced therapeutic effects are obtained because cortisol (an antiinflammatory substance) is drawn in much larger quantities to the afflicted area at 90 kHz than at l mHz. This is true when the externally applied conductive vehicle is the source of the cortisol or when a body organ of the patient is the source of the cortisol. In the latter case, large amounts of cortisol are drawn to the afflicted area with treatment at 90 kHz, while none is drawn by l mHz. Additionally, treatment at 90 kHz was found to produce a much greater beneficial physiologic effect on nerve tissue than on muscle tissue. Many of the advantages of using 90 kHz are contained in a prior art article entitled Ultrasonic Movement of Cortisol into Pig Tissue appearing in the American Journal of Physical Medicine. Vol. 44, No. I. pp. -25. Equipment for the experiments reported in this article was donated by the applicant's company, Mettler Electronics Corp.

However, treatment at kHz proved impractical because of a noise, audible only to the patient, set up in the patients body. The objectionable noise is highly irritating and is even more pronounced when treating the upper back or the head region. The noise is a screeching noise and makes treatment unbearable. As a result, treatment at 90 kHz has never been practical.

SUMMARY OF THE INVENTION Briefly, a preferred method of treating an afflicted member of a patients body according to the present invention involves the following steps: selecting an afflicted patient's member having skin, subcutaneous outer muscle and lower tissues, the lower tissues including muscle, nerve, bone and joint tissues; generating heat in the subcutaneous and outer muscle tissues at a localized area of the patients body in the afflicted member, causing an increase in temperature therein in the range of 1 C to 24 C; generating an ultrasonic mechanical vibratory energy wave having a frequency of kHz or greater; and simultaneously with the step of generating heat, coupling the mechanical vibratory energy wave to the same localized area to which heat is applied.

It has been found that such a method produces greatly enhanced therapeutic results in that much larger amounts of cortisol is driven from the surrounding tissue into the critical tissues, such as muscle, nerve, bone and joint tissues. Such a method also enables externally applied cortisol in ointment form to be drivenin much greater quantities into the critical tissues. A report on the unusual and greatly enhanced therapeutic values is disclosed in a publication within the last year in the Americal Journal of Medicine, copyright 1972 by The Williams &' Wilkins Co., Vol. 51, No. 2, in an article entitled Effects of Ultrasonic Frequency on Phonophoresis of Cortisol into Swine Tissues by Drs. Griffin and Touchstone.

Preferably, the foregoing method according to the invention is supplemented by applying an ointment coupling agent to the skin at the localized area and utilizing the coupling agent for coupling the mechanical vibratory energy wave thereby providing greater conductivity of the energy wave to the afflicted member.

In one embodiment of the present invention, the step of generating heat comprises the step of applying surface heat at the skin layer in the localized area.

According to a further preferred embodiment, the step of generating heat comprises the step of applying surface heat to the skin in the localized area in the range of l C. to 24 C above skin temperature.

According to an additional preferred embodiment of the invention, the step of generating the first named energy wave comprises the step of generating an energy wave having a frequency in the range of 150 kHz to 500 kHz wherein greater cortisol is driven to the lower tissues without requiring surface heat.

According to a still further preferred embodiment of the invention, the step of generating heat includes the steps of generating a further mechanical vibratory energy wave moving in a direction substantially parallel to the surface of the skin and coupling such wave to the subcutaneous and outer muscle tissue. The further energy wave is selected to generate heat in the subcutaneous and outer muscle tissue and the first mentioned energy wave is selected and extends in a direction substantially normal to the direction of the further energy wave to thereby generate heat at the lower tissues. Significantly, the combination of the two energy waves provides a substantially continuous heat throughout the subcutaneous outer muscle and lower tissues in the calized area. Greatly enhanced therapeutic results are obtained in that by such continuous heating, greater amounts of cortisol are driven. naturally from the body or from externally applied sources, into the critical lower tissues.

A further preferred embodiment of the invention involves the step of separately controlling the energy level of the first named energy wave, thereby enabling the level of heat in the subcutaneous and outer muscle tissue to be separately controlled.

According to another embodiment of the invention, there is an electro-mechanical therapeutic apparatus for treating an afflicted member as already defined. Therapeutic apparatus comprises an electrically energizable transducer having an applicator side, the transducer generating a first mechanical vibratory energy wave traveling in a direction normal to the applicator side and at a first frequency of at least 150 kHz selected for heating the lower tissues. In the therapeutic applicator there is provided a housing in which the transducer is mounted. An ultrasonic energy generating circuit is coupled to the transducer for exciting the transducer with an electrical signal and thereby causes a mechanical vibratory energy wave, both having at least one frequency component equal to the first frequency. Means is provided for generating adjacent the applicator side simultaneous with the mechanical vibratory energy wave. and in such subcutaneous and muscle tissues sufficient heat to cause a heat rise therein in the range of 1 C. to 24 C.

According to the preferred apparatus, the therapeutic applicator comprises an electrically energizable crystal having a first pair of substantially parallel sides spaced apart a distance determinative of a first resonant frequency and a second side normal to the pair of sides determinative of a second resonant frequency of at least 150 kHz. The second resonant frequency is selected for penetrating and heating the lower tissues. Included in the therapeutic applicator is a metallic electrode on each of the pair of crystal sides and a housing in which the crystal is mounted. A protective coating covers at least one of the pair of sides and forms an applicator side facing out of the housing. An ultrasonic energy generating circuit-is coupled across the metallic electrodes and generates across the crystal an ultrasonic frequency electrical signal and thereby a mechanical vibratory energy wave. The signal and mechanical vibratory energy wave have at least one frequency component equal to the second resonant frequency of the crystal. Means generates at the applicator side, simultaneously with the mechanical vibratory energy wave. and in the subcutaneous and outer muscle tissues, sufficient heat to cause a heat rise therein in the range of 1 C. to 24 C.

According to one embodiment of the invention. the means for generating heat comprises a heat radiator.

According to a further preferred embodiment of the invention, the heat radiator IS positioned at the applicator side so as to be positioned in between the afflicted member and applicator side.

uted mechanical vibratory field across the applicator side, cement connects the crystal and housing and the housing and cement are arranged so as to provide a space adjacent substantially all of the pair of sides to allow free movement of the applicator side in a direction normal to the pair of sides of the crystal.

A further preferred embodiment of the invention is one wherein the second resonant frequency is in the range of ISO to 500 kHz, allowing the driving of corti- 2 sol to lower muscle tissues without requiring surface heat.

According to a further preferred embodiment of the invention, the generating means forms an electrical signal having both first and second resonant frequencies 2 and the first resonant frequency is selected to generate the localized heat in the subcutaneous and outer muscle tissues.

According to a preferred arrangement of the preceding preferred embodiment, the generating means has a controllable signal generating circuit for controlling the level of mechanical vibratory energy at the first frequency.

BRIEF DESCRIPTION OF THE DRAWING FIG. 1 is a schematic and perspective view of an ultrasonic frequency electro-mechanical therapeutic apparatus and embodying the present invention;

FIG. 2 is a section view of the therapeutic applicator of FIG. 1 taken along the lines 22;

FIG. 3 is a cross-sectional view of a therapeutic applicator according to an alternate embodiment of the invention;

FIG. 4 is an alternate embodiment of the invention wherein a surface heat radiator is positioned in between the therapeutic applicator and the afflicted member being treated;

FIG. 5 is a perspective view of a crystal used to illustrate the principles of the present invention; and

FIG. 6 is a schematic representation of an alternate embodiment of the present invention wherein the separate signal generators are used to apply two different frequencies to the crystal so that the level of power at the two frequencies can be independently varied.

DESCRIPTION OF THE PREFERRED EMBODIMENT FIG. 1 is a schematic and perspective view of an ultrasonic frequency electro-mechanical therapeutic apparatus and embodies the present invention. The apparatus of FIG. I is for treating an afflicted member, having skin, subcutaneous, outer muscle and lower tissues of a patients body. The lower tissues include inner muscle, nerve, bone and joint tissues. The patient may g be a human or an animal. Specifically, the apparatus is for driving cortisol to the lower tissues from other parts of the body or from cortisol applied externally to the skin. Other elements beside cortisol may be driven'into the lower tissues within the broader concept of the invention.

Included is a therapeutic applicator 10. The therapeutic applicator includes a grounded metallic housing 12 connected to an energizing circuit 14. The energizing circuit 14 is a conventional electronic circuit well known in the crystal art for applying an ultrasonic frequency electrical signal across a piezoelectric crystal. Mechanically mounted in the housing 12 is a crystal 16. The crystal 16 is a disk-shaped piezoelectric crystal as typified by P16. 5, having a pair of substantially parallel circular surfaces 18 and 20 separating the surfaces 18 and 20, a circular side 22. A thin metallic electrode 24 covers the sides 18 and 22. A second thin metallic electrode 26 is positioned in a circular area (only part being shown in FIG. 2), near the center on the circular side 20. Two sides of the energizing circuit 14 are connected across the electrodes 24 and 26 as described hereinafter to thereby apply across the crystal 16 an ultrasonic frequency electrical signal causing the crystal to generate a mechanical vibratory energy wave. The

electrodes 24 and 26 are silver or other metals vacuum deposited or securely affixed to the crystal by other processes well known in the crystal art.

A protective coating material 26, such as plastic or metallic substances, extends over the exposed portion of the electrode 24 and, in particular, forms an applicator side 32. The electrode 24 is connected to the grounded metallic housing 12 by an electrically conductive adhesive 28 and 30. The electrically conductive adhesive 30 extends around the corner formed by the surface 20 of the crystal and the inside surface of the housing 12 to thereby provide a mechanical connection therebetween. However, it should be noted that the housing overlaps the side 32 only a short distance and the adhesive 30 only extends a very short distance over the bottom surface of the crystal 20, leaving free space adjacent substantially all of the sides 18, 20 and 22 to prevent restriction of movement of the crys tal allowing a substantially uniform distribution of mechanical vibratory energy across the applicator side. Other details of such a mounting are disclosed and described in applicant's US. Pat. Re. No. 25,657, the contents of which are incorporated herein by reference.

The energizing circuit 14 (shown only in FIG. 2) has conductors 31 and 31, 31 being grounded, which are soldered, welded or otherwise affixed to the housing 12 and the electrode 26, respectively.

Turn now to the typical example of the crystal 16 shown in FIG. 5. The parallel sides 18 and 20 are spaced apart a distance dl determinative of a first resonant frequency fl. The side 22 defines a diameter d2 or a dimension that is determinative of a second resonant frequency f2. According to the present invention, the resonant frequency fl is at least 150 kHz which is selected for heating the lower tissues of a patients body without causing the undesirable noise irritations. According to a preferred embodiment of the present invention, the frequency fl is in the range of 150 to 500 khz which achieves subcutaneous heating merely by selecting the proper crystal size without the need of applying surface heat. This feature will be explained in more detail hereinafter.

The energizing circuit 14 is coupled across the electrodes 24 and 26 and provides an ultrasonic frequency electrical signal fl across the crystal, thereby causing a mechanical vibratory energy wave from the crystal having at least one ultrasonic frequency component equal to the resonant frequency f1.

According to the invention, means is provided for generating heat adjacent the applicator side 32 of the crystal, simultaneously with the mechanical vibratory energy wave. The heat is generated in the subcutaneous and outer muscle tissues and is sufficient to cause a heat rise therein in the range of 1C. to 24 C. Preferably, the heat rise is in the range of 5 C. to 24 C. The heat rise formed at the skin surface is in the range of 5 C. to 24 C. The mechanical vibratory energy wave created by the resonant frequency fl acts in an axial direction of the crystal, thereby penetrating to the lower tissues where the inner muscle, nerve, bone and joint tissues lie. The heat generated in the subcutaneous and outer muscle tissues, together with heat created by the ultrasonic frequency fl at lower tissues, causes a continuous temperature rise in the subcutaneous outer muscle and lower tissues. This continuous heat in combination with the agitation created by the ultrasonic signal at frequency fl causes cortisol to be driven to the critical lower tissues.

Referring to FIG. 4, one embodiment of the invention is shown for generating the heat and comprising a conventional heat pad 34. It will be noted that the heat pad or radiator 34 is positioned at the applicator side 32 in between the applicator side 32 and the afflicted member to be treated.

According to another and a preferred embodiment of the invention, a crystal 16, as shown in FIGS. 1 and 2, is used having parallel sides 18 and 20, each with an area in the range of 2 to 15 cm By providing such area on the crystal with the aforementioned ranges in frequency, it is a known scientific fact that an ultrasonic mechanical vibratory energy wave is formed, moving substantially parallel with the applicator side 32 and these energy waves generate heat in the subcutaneous and upper muscle tissues. Thus, according to the preferred embodiment of the invention, the shape of the crystal and the energizing circuit 14 form the means for generating heat in the subcutaneous and outer muscle tissues.

Refer now to the alternate embodiment of the invention shown in FIG. 6. in the alternate embodiment of the invention shown in FIG. 6, a parallelepiped crystal 36 is shown having parallel spaced apart sides 38 and 39 separated by parallel spaced apart sides 40 and 42. The spacing between sides 38 and 39 is a distance which determines a first resonant frequency of the crystal and the spacing between the sides 40 and 42 determines a second resonant frequency of the crystal. Provided on each of the parallel sides 38 and 39 is a metallic electrode 44 affixed in a well known manner in the crystal art. (The electrode 44 on the surface 40 not being shown). Electrodes 41 are affixed on the sides 39 and 42 in the same manner as electrodes 44. (The electrode on side 42 not being shown).

Variable power level electrical signal generator 46 is connected across the electrodes 44 and variable power level electrical signal generator 48 is connected across the electrodes 41. The frequency of the signal formed by the generator 46 is equal to the resonant frequency between sides 38 and 39 and the frequency of the signal formed by generator 48 is equal to the resonant frequency determined by the spacing between sides 39 v and 42. The amount of power delivered by each of the generators 46 and 48 is variable. As a result, it is possible to control the power level of the mechanical vibratory energy wave generated at one frequency independently of the level generated at the other frequency. The parallelepiped crystal illustrated in FIG. 6 may be mounted in the manner illustrated in the abovementioned US. Pat. Re. No. 25,657. The applicator side of the crystal may be the side 38 with a protective coating (not shown) covering the applicator side.

The sides 38 and 39 are determinative of a resonant frequency of at least 150 kHz and preferably of a resonant frequency in the range of I50 to 500 kHz for the reasons discussed above. The mechanical energy wave determined by the resonant frequency between sides 39 and 42 moves in a direction parallel with side 38 and heats the subcutaneous and outer muscle tissues whereas the mechanical energy wave determined by the resonant frequency between sides 38 and 40 moves normal to side 38 and heats and treats the lower tissues.

In the embodiment shown in FIG. 6, the generator 48 and the crystal 36 form the means for generating adjacent the applicator side, simultaneously with the mechanical vibratory energy, and in the subcutaneous layer, the proper amount of heat to cause a heat rise in the subcutaneous and outer muscle in the range of 1 C. to 24 C. and a rise in skin temperature in the range of 5 C. to 24 C. This is accomplished by selecting a dimension between sides 40 and 42 so as to determine a resonant frequency of the crystal to generate the required subcutaneous and outer muscle tissues heat.

Instead of providing separate electrodes on separate sides, the generators may be connected across electrodes on only two sides. For example, the electrodes may be split into two electrically separate electrodes on one side and the two generators connected between a single electrode on one side and the separated electrodes on the other.

The separate generators of FIG. 6 may be replaced with a single generator which provides a signal across two sides having two frequencies. One example of such a generator is disclosed in applicants US. Pat. No. 3,180,626 which is incorporated herein by reference.

FIG. 3 shows an alternate embodiment of the applicator 10 according to the invention and illustrates an alternate way in which the disk-shaped crystal 16 shown in FIGS. 2 and 5 may be mounted. Specifically, the crystal 16 shown in FIG. 3 has an electrode 26 identical to that shown in FIG. 2 with an alternate electrode 50 which completely covers the side 18, the side 22 and slightly into the side 20. The corner of the metallic electrode 50 is wedged into a metallic housing 52. The housing 52 has a flared annular area 54 which extends away from the side of the electrode 50 adjacent the side 22 of the crystal. Electrically conductive epoxy 56 is positioned in the flared annular area between the electrode 50 and the housing 52 to rigidly connect the two together. A plastic covering 58 extends over the exposed portion of the electrode 50. A coaxial cable 60 from an energizing circuit such as 14 has a center wire 62 connected to the electrode 26 and a grounded shield wire 64 which is soldered to-the metallic housing 52.

Preferably, the crystals shown in the drawings are of a barium titanite material. However, within the broader concepts of the invention, the crystal may be any one of a number of different types of crystals which, when electrically energized with an ultrasonic frequency electrical signal, will generate ultrasonic mechanical vibratory energy. For example, the crystal may be lead zirconate.

Within the broader concepts of the present invention, the crystal may take on other shapes besides disk shape and parallelepiped shape. For example, crystal may be oval-shaped.

It should also be understood that within the very broad concepts of one embodiment of this invention that the heating means may take the form of an electrical signal generator together with a crystal having a low .power factor, thereby generating sufficient heat to heat the subcutaneous layer within the prescribed heat range.

The broader concepts of the invention involve other types of electrical to mechanical transducers for generating ultrasonic mechanical energy waves. For example, electromagnetostrictive apparatus such as ferrite or nickel may be used in place of a crystal as the transducer, provided they are designed to provide similar characteristics to those described hereinabove.

It should also be noted that the range of resonant frequency of kHz to 500 kHz is a preferred range and the upper limit of 500 kHz is required in those situations where a separate heat radiator is not provided for applying the heat. In the absence of a separate heat radiator, it has been found that the improved biological effects diminish and essentially no cortisone is developed in the lower tissues when the frequencies reach 800 kHz. However, when a separate radiator is used, improved biological effects are achieved at even higher frequencies of ultrasonic mechanical vibratory energy waves.

According to the foregoing teachings, the following steps form a method of treating an afflicted member of a patient's body according to the present invention: selecting an afflicted member having skin, subcutaneous, outer muscle and lower tissues. Generating heat in the subcutaneous and outer muscle tissues at a localized area of the patients body in the afflicted member, causing an increase in temperature in the subcutaneous and outer muscle tissues in the range of 1 C. to 24 C. It is important that the heat be applied at a localized area since with general application of heat and ultrasound, it is not possible to cause the increased biological effects at the critical lower tissues of interest. The steps also include the step of generating an ultrasonic mechanical vibratory energy wave having a frequency of at least 150 kHz. Simultaneously with the step of generating heat, the energy wave is coupled to the same localized area as the heat is applied.

It is important that the mechanical energy waves moving parallel with the applicator surface (i.e. surface 32 of FIG. 2) be coupled to the afflicted member. In order to improve the coupling of the mechanical vibratory energy, preferably an aqueous ointment coupling agent such as oil or water base materials, is applied to the skin of the afflicted member at the localized area and is utilized for coupling the mechanical vibratory energy to the afflicted member. The ointment may contain the external cortisol or other medicine.

One form of generating the heat includes the step of applying surface heat to the skin in the localized area.

Preferably the step of applying surface heat to the skin in the localized area includes the ste'p of applying heat in the range of C. to 24 C. above skin temperature.

According to a preferred embodiment of the invention, the first named energy wave has a frequency in the range of 150 kHz to 500 kHz.

In place of the separate heat radiator, the step of generating the heat may involve the step of generating a further mechanical vibratory energy wave moving in a direction substantially parallel to the surface of the skin and coupling such mechanical vibratory energy wave to the subcutaneous and outer muscle tissues in the afflicted member, such as by direct contact with or without a coupling ointment. This procedure as described hereinabove may be accomplished by selecting the correct applicator surface area for the crystal or by energizing the crystal with signals having different frequencies. The mechanical vibratory energy wave is selected to generate heat in the subcutaneous layer and extend in a direction which is substantially normal to the surface of the skin. Thus, the combination of the two energy waves provide substantially uniform heating through the subcutaneous and lower tissue layers in the localized area.

Preferably, the energy level of one of the energy waves is variable and controlled to thereby generate the proper amount of heat in the subcutaneous and outer muscle tissue.

Although an exemplary embodiment of the invention has been disclosed for purposes of illustration, it will be understood that various changes, modifications and substitutions may be incorporated in such embodiment without departing from the spirit of the invention as defined by the claims appearing hereinafter.

What is claimed is:

l. A method of treating an afflicted member of a patient's body comprising the steps of:

a. selecting such an afflicted member having skin, subcutaneous, outer muscle and lower tissues, the lower tissues including inner muscle, nerve, bone or joint tissues;

b. generating heat in the subcutaneous and outer muscle tissues at a localized area of the patients body in the afflicted member, causing an increase in temperature therein in the range of 1C. to 24 C.;

c. generating an ultrasonic mechanical vibratory energy wave having a frequency of at least l50 kHz; and

d. simultaneously with the step of generating heat coupling said mechanical vibratory energy wave to the same localized area.

2. The method of claim 1 including the step of applying an ointment coupling agent to the skin of the afflicted member at the localized area and utilizing the coupling agent for coupling the mechanical vibratory energy wave.

3. The method of claim 1 wherein the step of generating heat comprises the step of applying surface heat to the skin in the localized area.

4. The method of claim 3 wherein the step of generating heat comprises the step of applying surface heat to the skin in the localized area in the range of 5C. to 24 C. above skin temperature.

5. The method of claim 4 wherein the step of generating the first named mechanical vibratory energy wave comprises the step of generating energy waves having a frequency in the range of 150 kHz to 500 kHz.

6. Themethod of claim 1 wherein the step of generating heat comprises the steps of generating a further mechanical vibratory energy wave moving in a direction substantially parallel to the surface of the skin and coupling the same to the subcutaneous and outer muscle tissues in the afflicted member, the further energy wave being selected to generate heat in the subcutaneous and outer muscle tissues and the first mentioned energy wave being selected and extending in a direction substantially normal to the further energy wave to thereby generate heat at the lower tissues, the combination of energy waves providing a continuous heating effect through the subcutaneous and outer muscle and lower tissues in the localized area.

7. The method of claim 6 including the step of separately controlling the energy level of one of the energy waves.

8. Ultrasonic frequency electro-mechanical therapeutic apparatus for treating an afflicted member, having skin, subcutaneous outer muscle and lower tissues, of a patients body, the lower tissues including inner muscle nerve, bone or joint tissues, the combination comprising:

a. therapeutic applicator comprising:

l. an electrically energizable crystal for generating mechanical energy having a first pair of substantially parallel sides spaced apart a distance determinative of a first resonant frequency and a second side normal to said first pair of sides determinative of a second resonant frequency of at least kHz selected for heating the lower tissues,

2. a metallic electrode on each of said pair of sides,

3. a housing in which said crystal is mounted,

4. a protective coating covering at least one of said pair of sides and forming an applicator side facing out of said housing,

b. ultrasonic energy generating circuit coupled across the metallic electrodes and generating across said crystal an ultrasonic electrical signal and thereby mechanical vibratory energy, both having at least one frequency component equal to said second resonant frequency; and

c. means for generating adjacent said applicator side simultaneously with said mechanical vibratory energy, and in the subcutaneous and outer muscle tissues in the afflicted member sufficient heat to v cause a heat rise therein in the range of 1 C. to 24 C.

9. The apparatus of claim 8 wherein said means for generating heat comprises a heat radiator.

10. The apparatus of claim 9 wherein said heat radiator is positioned at said applicator side so as to be positioned in between the afflicted member and applicator side.

11. The apparatus of claim 8 wherein said at least one side of said crystal has an area in the range of 2 to 15 cm thereby causing an ultrasonic mechanical vibratory energy wave to be formed, moving substantially parallel with said applicator side and thereby forming said means for generating heat in the subcutaneous layer.

12. The apparatus of claim 11 comprising cement connected between said crystal and housing the cement and housing providing a space adjacent substantially all of said pair of sides to permit free moveme nt of the applicator side in a direction normal to said pair of sides of the crystal to thereby cause a uniform distribution of energy across said applicator side.

13. The apparatus of claim 12 wherein said at least one side of said crystal has an area in the range of 2 to l5 cm thereby causing an ultrasonic mechanical vibratory energy wave to be formed, moving substantially parallel with said applicator side and thereby forming said means for generating heat in the subcutaneous and outer muscle tissues.

14. The generator of claim 8 wherein said second resonant frequency is in the range of l5O to 500 kHz.

15. The apparatus of claim 14 wherein said heat radiator is positioned at said applicator side so as to be positioned in between the afflicted member and applicator side.

16. The generator of claim 11 wherein said second resonant frequency is in the range of 150 to 500 kHz.

17. The generator of claim 16 wherein said generating means comprises controllable signal generating means for controlling the level of mechanical vibratory energy generated at said first frequency.

18. The generator of claim 8 wherein said generating means generates an electrical signal having both said first and second resonant frequencies, the first resonant frequency being selected to generate said localized heat in the subcutaneous and outer muscle tissues.

19. Ultrasonic frequency electro-mechanical therapeutic apparatus for treating an afflicted member, having skin, subcutaneous outer muscle and lower tissues, of a patients body, the lower tissues including inner muscle, nerve, bone and joint tissues, the combination comprising:

a. therapeutic applicator comprising:

1. an electrically energizable transducer having an applicator side for generating mechanical energy, the transducer generating a first mechanical vibratory energy wave traveling in a direction normal to said applicator side and at a frequency of at least I50 kHz selected for heating the lower tissues,

2. a housing in which said transducer is mounted,

b. ultrasonic energy generating circuit coupled to the transducer for exciting the transducer with an electrical signal and thereby causes a mechanical vibratory energy wave, both having at least one frequency component equal to said frequency of at least 150 kHz; and

c. means for generating adjacent said applicator side simultaneously with said mechanical vibratory energy wave, and in such subcutaneous and outer muscle tissues sufficient heat to cause a heat rise therein in the range of 1 C, to 24 C. 20. The generator of claim 19 wherein said second resonant frequency is in the range of l50 to 500 kHz.

21. The apparatus of claim 12 wherein said means for generating heat comprises a heat radiator.

22. The generator of claim 19 wherein said generating means generates an electrical signal having both said first and a second resonant frequency, the second resonant frequency being selected to generate said localized heat in the subcutaneous and outer muscle tissues.

23. The generator of claim 22 wherein said generating means comprises controllable signal generating means for controlling the level of mechanical vibratory energy generated at said second frequency.

24. Ultrasonic frequency electro-mechanical therapeutic apparatus for treating an afflicted member, having skin, subcutaneous outer muscle and lower tissues, of a patients body, the lower tissues including inner muscle, nerve bone, or joint tissues, the combination comprising:

a. therapeutic applicator comprising:

l. an electrically energizable crystal for generating mechanical energy having a first pair of substantially parallel sides spaced apart a distance determinative of a first resonant frequency and a second side normal to said first pair of sides determinative of a second resonant frequency of at least l50 kHz selected for heating the lower tissues,

2. a metallic electrode on each of said pair of sides, 

1. A method of treating an afflicted member of a patient''s body comprising the steps of: a. selecting such an afflicted member having skin, subcutaneous, outer muscle and lower tissues, the lower tissues including inner muscle, nerve, bone or joint tissues; b. generating heat in the subcutaneous and outer muscle tissues at a localized area of the patient''s body in the afflicted member, causing an increase in temperature therein in the range of 1* C. to 24* C.; c. generating an ultrasonic mechanical vibratory energy wave having a frequency of at least 150 kHz; and d. simultaneously with the step of generating heat coupling said mechanical vibratory energy wave to the same localized area.
 2. The method of claim 1 including the step of applying an ointment coupling agent to the skin of the afflicted member at the localized area and utilizing the coupling agent for coupling the mechanical vibratory energy wave.
 2. a metallic electrode on each of said pair of sides,
 2. a metallic electrode on each of said pair of sides,
 2. a housing in which said transducer is mounted, b. ultrasonic energy generating circuit coupled to the transducer for exciting the transducer with an electrical signal and thereby causes a mechanical vibratory energy wave, both having at least one frequency component equal to said frequency of at least 150 kHz; and c. means for generating adjacent said applicator side simultaneously with said mechanical vibratory energy wave, and in such subcutaneous and outer muscle tissues sufficient heat to cause a heat rise therein in the range of 1* C. to 24* C.
 3. a housing in which said crystal is mounted, b. ultrasonic energy generating circuit coupled across the metallic electrodes and generating across said crystal an ultrasonic electrical signal and thereby mechanical vibratory energy, both having at least one frequency component equal to said second resonant frequency; and c. means for generating adjacent said applicator side simultaneously with said mechanical vibratory energy, and in the subcutaneous and outer muscle tissues in the afflicted member sufficient heat to cause a heat rise therein in the range of 1* C. to 24* C.
 3. a housing in which said crystal is mounted,
 3. The method of claim 1 wherein the step of generating heat comprises the step of applying surface heat to the skin in the localized area.
 4. The method of claim 3 wherein the step of generating heat comprises the step of applying surface heat to the skin in the localized area in the range of 5* C. to 24* C. above skin temperature.
 4. a protective coating covering at least one of said pair of sides and forming an applicator side facing out of said housing, b. ultrasonic energy generating circuit coupled across the metallic electrodes and generating across said crystal an ultrasonic electrical signal and thereby mechanical vibratory energy, both having at least one frequency component equal to said second resonant frequency; and c. means for generating adjacent said applicator side simultaneously with said mechanical vibratory energy, and in the subcutaneous and outer muscle tissues in the afflicted member sufficient heat to cause a heat rise therein in the range of 1* C. to 24* C.
 5. The method of claim 4 wherein the step of generating the first named mechanical vibratory energy wave comprises the step of generating energy waves having a frequency in the range of 150 kHz to 500 kHz.
 6. The method of claim 1 wherein the step of generating heat comprises the steps of generating a further mechanical vibratory energy wave moving in a direction substantially parallel to the surface of the skin and coupling the same to the subcutaneous and outer muscle tissues in the afflicted member, the further energy wave being selected to generate heat in the subcutaneous and outer muscle tissues and the first mentioned energy wave being selected and extending in a direction substantially normal to the further energy wave to thereby generate heat at the lower tissues, the combination of energy waves providing a continuous heating effect through the subcutaneous and outer muscle and lower tissues in the localized area.
 7. The method of claim 6 including the step of separately controlling the energy level of one of the energy waves.
 8. Ultrasonic frequency electro-mechanical therapeutic apparatus for treating an afflicted member, having skin, subcutaneous outer muscle and lower tissues, of a patient''s body, the lower tissues including inner muscle nerve, bone or joint tissues, the combination comprising: a. therapeutic applicator comprising:
 9. The apparatus of claim 8 wherein said means for generating heat comprises a heat radiator.
 10. The apparatus of claim 9 wherein said heat radiator is positioned at said applicator side so as to be positioned in between the afflicted member and applicator side.
 11. The apparatus of claim 8 wherein said at least one side of said crystal has an area in the range of 2 to 15 cm2 thereby causing an ultrasonic mechanical vibratory energy wave to be formed, moving substantially parallel with said applicator side and thereby forming said means for generating heat in the subcutaneous layer.
 12. The apparatus of claim 11 comprising cement connected between said crystal and housIng the cement and housing providing a space adjacent substantially all of said pair of sides to permit free movement of the applicator side in a direction normal to said pair of sides of the crystal to thereby cause a uniform distribution of energy across said applicator side.
 13. The apparatus of claim 12 wherein said at least one side of said crystal has an area in the range of 2 to 15 cm2 thereby causing an ultrasonic mechanical vibratory energy wave to be formed, moving substantially parallel with said applicator side and thereby forming said means for generating heat in the subcutaneous and outer muscle tissues.
 14. The generator of claim 8 wherein said second resonant frequency is in the range of 150 to 500 kHz.
 15. The apparatus of claim 14 wherein said heat radiator is positioned at said applicator side so as to be positioned in between the afflicted member and applicator side.
 16. The generator of claim 11 wherein said second resonant frequency is in the range of 150 to 500 kHz.
 17. The generator of claim 16 wherein said generating means comprises controllable signal generating means for controlling the level of mechanical vibratory energy generated at said first frequency.
 18. The generator of claim 8 wherein said generating means generates an electrical signal having both said first and second resonant frequencies, the first resonant frequency being selected to generate said localized heat in the subcutaneous and outer muscle tissues.
 19. Ultrasonic frequency electro-mechanical therapeutic apparatus for treating an afflicted member, having skin, subcutaneous outer muscle and lower tissues, of a patient''s body, the lower tissues including inner muscle, nerve, bone and joint tissues, the combination comprising: a. therapeutic applicator comprising:
 20. The generator of claim 19 wherein said second resonant frequency is in the range of 150 to 500 kHz.
 21. The apparatus of claim 12 wherein said means for generating heat comprises a heat radiator.
 22. The generator of claim 19 wherein said generating means generates an electrical signal having both said first and a second resonant frequency, the second resonant frequency being selected to generate said localized heat in the subcutaneous and outer muscle tissues.
 23. The generator of claim 22 wherein said generating means comprises controllable signal generating means for controlling the level of mechanical vibratory energy generated at said second frequency.
 24. Ultrasonic frequency electro-mechanical therapeutic apparatus for treating an afflicted member, having skin, subcutaneous outer muscle and lower tissues, of a patient''s body, the lower tissues including inner muscle, nerve bone, or joint tissues, the combination comprising: a. therapeutic applicator comprising: 